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Recruiting Not applicable

Single Stage Versus Multiple Staged Repair of Nasal & Alveolar Deformities in Patients With Cleft Lip and Palate

NCT06510881 · tracked via the Priya Life Science Egypt tracker
Phase
Not applicable
Started
2024-07-20
Last updated
2024-07-19

Condition(s) studied

Cleft Lip and PalateRhinoplasty

Investigational drug(s) / intervention(s)

Rhinoplasty with or without cleft alveolus repair

Rhinoplasty with or without cleft alveolus repair: * Group (A) : Correction of nasal deformity will be carried out using costochondral cartilage strut for support of septum and lengthening of columella . A concomitant iliac bone graft is taken to reconstruct the alveolar bone . This group age will be above 8 years . * Group (B) : Patients who present early before age of 8 years will have rhinoplasty session only . Another session will be prepared for cleft alveolus at age of 8 years .

Study summary

Cleft lip and palate patients are commonly seen among maxillofacial patients. Patients with cleft lip and palate have evident cosmetic nasal deformities. The interrupted insertion of orbicularis oris muscle into the columella on the noncleft side forces the premaxilla, columella and caudal nasal septum towards that side. At the same time, as the orbicularis oris inserts into the alar base on the cleft side, the base is pulled laterally, inferiorly and posteriorly. The malformed lower lateral cartilage on the side of the cleft contributes majorly to the deformity of the nasal tip, causing it to be more blunt. A shorter medial crus and longer lateral crus on the cleft side results in a horizontally wider and displaced nostril on the cleft side. In addition, those patients have alveolar bone defect which results in both cosmetic and dental problems. Repair of the deformed nose along with the reconstruction of the alveolar defect may have an advantage over the staged repair in:- decrease the surgical burden on the patient , correction of the facial asymmetry by redeeming the maxillary bony support , peri-alar augmentation and accordingly obtaining faster and better socio-cosmetic benefit .

Eligibility

Sex
ALL
Min age
5 Years
Max age
18 Years
Healthy volunteers
Accepted
Inclusion Criteria: \- Patients with unilateral cleft lip and palate deformities with evident nasal and cleft lip and palate aged between 5 - 18 years. Exclusion Criteria: * \* Patients with bilateral complete cleft palate . * Patients with only cleft lip. * Patients with cleft secondary palate. * Patients non fit for surgery. * Patients refuse the consent.

Primary outcome measure(s)

  • Evaluation of SCHNOS criteria in both groups for evaluation of both cosmetic and functional improvement . The patients will be assessed on the scale and compared between the obtained pre and post operative results after 6 months of surgery . — 6 months after surgery
    1. Having a blocked or obstructed nose 2. Getting air through my nose during exercise 3. Having a congested nose 4. Breathing through my nose during sleep 5. Decreased mood and self-esteem due to my nose 6. The shape of my nasal tip 7. The straightness of my nose 8. The shape of my nose from the side 9. How well my nose suits my face 10. The overall symmetry of my nose

Trial sites (1)

FacilityCityRegionStatus
Assiut university Asyut Egypt Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06510881 on ClinicalTrials.gov ↗ ← All trials in Egypt